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Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

NCT00241722 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2017-08-30

No results posted yet for this study

Summary

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Conditions

Interventions

DRUG

Alvimopan

DRUG

Placebo

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials, MD · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-01
Primary Completion
2007-02-01
Completion
2007-02-01

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Denmark
  • Finland
  • Hong Kong
  • Hungary
  • Ireland
  • Netherlands
  • New Zealand
  • Poland
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00241722 on ClinicalTrials.gov